Nimbus - Ambulatory Infusion Pump - ZYNO MEDICAL LLC

Duns Number:030899271

Device Description: Ambulatory Infusion Pump

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More Product Details

Catalog Number

Nimbus

Brand Name

Nimbus

Version/Model Number

Nimbus

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2016

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FRN

Product Code Name

Pump, Infusion

Device Record Status

Public Device Record Key

b6d9b2b2-3208-4c08-8b3f-587f6d3eab7e

Public Version Date

July 04, 2022

Public Version Number

4

DI Record Publish Date

October 13, 2015

Additional Identifiers

Package DI Number

10814371020041

Quantity per Package

24

Contains DI Package

00814371020044

Package Discontinue Date

September 23, 2016

Package Status

Not in Commercial Distribution

Package Type

Box

"ZYNO MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19